Halyard 47629Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651476290), received between Sep 26, 2024 and Sep 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Contamination; Contamination

  THE CUSTOMER REPORTED FOREIGN MATERIAL IN THE FOLD OF THE 3/4" DRAPE. THE FOREIGN DEBRIS CONTAMINATED STERILE FIELD, INCLUDING PREPPED INSTRUMENTS. THE ISSUE WAS IDENTIFIED AFTER THE PATIENT WAS DRAPED BUT PRIOR TO INCISION. THE OR ROOM HAD TO BE CLEANED WHILE PATIENT WAS UNDER ANESTHESIA AND A NEW STERILE FIELD CREATED INCLUDING NEW SUPPLIES AND INSTRUMENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20312067 ↗